What are the responsibilities and job description for the Supervisor Quality Control position at Bend Bioscience?
About the job
Why Join Bend Bioscience?
Mission And Culture
At Bend Bioscience, we Advance Health Through Innovation by developing and manufacturing therapies that improve patients' quality of life. We believe every employee plays a vital role in our mission to advance human health through innovative client partnerships. Whether you’re involved in development, manufacturing, testing, or contributing your expertise in other areas, your work will have a meaningful, positive impact on countless lives.
Do You
Love finding new and better ways to do things?
Want to help develop medicines that improve patients' lives?
Have a passion for learning and growth?
Nerd out on science and technology?
Value collaboration and teamwork?
Embrace audacity and entrepreneurial thinking?
Prioritize safety and lead by example?
Care deeply about doing the right thing?
At Bend Bioscience, we foster a diverse, inclusive, challenging, and supportive culture. We are committed to continuous improvement, both as individuals and as an organization, and we encourage personal and professional development at every level. Join us to make a real difference in patients’ lives through your work.
Your New Role At Bend Bioscience
In this role, you will oversee the daily operations of a group of analysts responsible for testing within the laboratory and performed in compliance with cGMP and internal written procedures and policies. You will answer questions that arise regarding cGMP and internal requirements of a particular activity or job function. You will also communicate any non-compliant activities to QC management without delay. You will be accountable for the accuracy, integrity, and security of all results generated by the working group.
Key Responsibilities (other Duties May Be Assigned)
Review and approve data packages for finished product, stability samples, raw materials and components, and in-process materials, for submission to QA for final disposition
Trending of test results to identify potential excursions from normal operating parameters
Assign testing based upon priorities and available resources and trained personnel.
Supervise testing to ensure compliance with all applicable procedures, and timely completion.
Ensure compliance with the change control policy, and other site wide programs (i.e. documentation)
Write, revise or review SOP’s, analytical protocols, specifications, and controlled forms.
Ensure subordinate staff is adequately trained to perform job assignments. Execute training in accordance with written procedures, once certified as a qualified trainer. This would include but is not limited to training subordinate staff, perform training assessments, document training, and assist in the preparation of training programs and curricula
Ensure compliance with DEA regulations and internal controlled substances security and reconciliation programs on a day-to-day basis. May be assigned the function of controlled substance steward with the overall lab responsibility for reconciliation of all controlled substances under the control of the QC department.
Lead Or Supervisory Responsibilities
Provides day to day leadership of the QC Department. (Supervisor only)
Identifies, recruits, and retains top-notch talent.
Sets performance standards and supports growth through delegation, continuous feedback, goal setting, and performance management.
Supports a diverse and inclusive culture and team.
Champions Bend Bioscience’s culture and empowers employees to take ownership of their learning and growth.
Maintain transparent communication. Appropriately communicate organization information through department meetings, one-on-one meetings, email, and regular interpersonal communication.
Provide oversight and direction to the team members in accordance with Bend Bioscience's policies and procedures.
Experience And Educational Requirements
B.S/B.A. in a chemistry related scientific discipline (e.g., chemistry, chemical engineering, pharmacy)
A minimum of six (6) years working directly in a cGMP environment in either Quality Control lab or an Analytical Development Lab or a combination of the two for a pharmaceutical company focusing on solid oral dose products.
Two years (2) Prior supervisory experience including hiring, goal setting, terminating, training and developing, reviewing performance and administering corrective action for staff, is highly preferred.